By Monte Morin
2:01 PM EDT, May 8, 2013
The U.S. Food and Drug Administration has announced the recall of several dietary supplements that contain the undeclared drug tadalafil, which is used to treat erectile dysfunction.
The products -- SexVoltz, Velextra, and Amerect -- were manufactured by BeaMonstar Products of Queen Creek, Ariz., and were distributed nationally, according to the FDA.
"These undeclared active ingredients pose a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels," read an FDA notice of the recall.
"Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. BeaMonstar Products has not received any reports of adverse events to date related to this recall."
Tadalafil is FDA-approved. The products were being sold as dietary supplements, however, and the agency considered them to be unapproved new drugs.
The affected SexVoltz brand SKU’s are 626570609490, 827912089028, 626570617877, 626570615316. The affected Velextra brand SKU’s are 626570619475, 626570619475, 626570619475, 626570619475. Amerect SKU’s are 626570619031 and 626570619598, according to the FDA.
The affected "Maximum Strength" SexVoltz, Velextra, and Amerect are all lots distributed and sold from January 2012 to May 7, 2013, and contain various expiration dates.
BeaMonstar Products is arranging for credit of all recalled products, the FDA said. Consumers should return the product to the place of purchase.
Consumers with questions regarding this recall can contact BeaMonstar Products at (480) 735-1424 or firstname.lastname@example.org. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
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